Merck's Diabetes Franchise And The Perils In Proving A Drug's Medical Value
Merck’s Januvia (sitagliptin) and its metformin combination, Janumet, are important drugs for type 2 diabetes patients as well as for Merck’s bottom line. These drugs, which are DPP-4 inhibitors, account for more than $6 billion in sales for this drug giant. Given the growing incidence of obesity and type 2 diabetes in the world, this franchise is poised for continued growth. However, Merck has competition in this field with a number of other drug companies, a notable one being Eli Lilly. Lilly has a variety of products for diabetics, including Jardiance (empagliflozin), a drug that acts by blocking SGLT2. (Lilly co-developed Jardiance with Boehringer Ingelheim.) Both Januvia and Jardiance lower high blood sugar, the cause of the downstream consequences of diabetes such as heart disease, kidney failure, blindness and amputations. However, just because a drug lowers blood sugar doesn’t ensure that it will reduce the ultimate complications of diabetes. Nevertheless, over the years diabetes drugs have been approved on the basis of blood sugar lowering alone. However, last December, Lilly raised the bar for oral diabetes drugs with the acceptance by the FDA of its data showing that Jardiance not only lowered blood sugar but, in doing so, also reduced cardiovascular events in diabetic patients with heart disease. These data were generated in a trial known as the EMPA-REG OUTCOME trial. Last December, the FDA effectively blessed this work and allowed Lilly to add the cardiovascular outcome benefit to the Jardiance label. This was a big advantage to Lilly because its sales reps are now allowed to talk to prescribing physicians about these data. Merck, however, was not operating in a vacuum. It, too, had a similar outcome study underway, known as TECOS (“Trial Evaluatin Continue reading >>
Study Reveals Benefits Of Jardiance And Metformin Combination Therapy In Type 2 Diabetes
Type 2 diabetes patients who struggle to control their blood sugar could achieve better HbA1c levels through taking Jardiance (empagliflozin) and metformin, research suggests. These are the findings of a new study which compared empagliflozin and metformin as first-line therapy compared to patients who took either drug as a monotherapy. Samy Hadjadj, MD, PhD, Poitiers University Hospital, France and colleagues conducted this study, which involved 1,364 patients with type 2 diabetes who were not taking medication beforehand. All the participants had an HbA1c greater than 7.5% (58.5 mmol/mol), and were randomised to 24 weeks of treatment either with varying doses of empagliflozin and metfomin together, empagliflozin on its own, or metformin on its own. The participants were evaluated at baseline and weeks six, 12, 18 and 24, with follow-up visits conducted seven days after the last intake of the study drug. All treatment groups experienced reductions in HbA1c, but the highest reductions occurred among patients taking empagliflozin and metformin twice daily. Patients in the combination therapy group also experienced greater weight loss compared to those taking metformin alone, as well as more significant reductions in blood pressure. However, the improvements in blood pressure were not greater in the combination therapy group when compared to the empagliflozin alone group. "This was as expected given that empagliflozin has consistently been shown to reduce BP in patients with type 2 diabetes," said the researchers. "The mechanisms behind reductions in BP with empagliflozin have not been fully clarified but may reflect weight loss, volume contraction secondary to osmotic diuresis or arterial stiffness." The drug combination was well tolerated by patients and did not increas Continue reading >>
Did This Clinical Study Just Show Merck's Best-selling Drug The Door?
Did This Clinical Study Just Show Merck's Best-Selling Drug the Door? Are DPP-4 inhibitors like Januvia on their way out? A new long-term study from partners Eli Lilly and Boehringer Ingelheim suggests it's a possibility. A Fool since 2010, and a graduate from UC San Diego with a B.A. in Economics, Sean specializes in the healthcare sector and investment planning. You'll often find him writing about Obamacare, marijuana, drug and device development, Social Security, taxes, retirement issues and general macroeconomic topics of interest. Follow @TMFUltraLong Like most Big Pharma stocks,Merck ( NYSE:MRK ) has endured a bumpy ride this decade due to the loss of exclusivity on key drugs (affably known as the patent cliff) and a general increase in competition. Despite these challenges, Merck has one rock that it continues to lean on: Januvia (which is known as Janumet in overseas markets). Januvia/Janumet is Merck's $6 billion per year oral diabetes medicine, a DPP-4 inhibitor. Januvia/Janumet is specifically designed for type 2 diabetes, and works by lowering blood sugar in patients when it gets too high. In recent quarters, growth for Januvia/Janumet has reaccelerated -- and rightly so. First, the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (the scientific name for Januvia), or TECOS, was presented in June at the Scientific Sessions of the American Diabetes Association and simultaneously published in The New England Journal of Medicine, showing that Januvia met its primary endpoint of not increasing major cardiovascular events as it relates to hospitalization or heart failure compared to the placebo. This study was meant to reassure physicians and consumers that long-term use of Januvia wasn't going to harm their cardiovascular system (and it was also a post Continue reading >>
Government Warns About New Class Of Type 2 Diabetes Drugs
The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization. The oral drugs belong to a class known as SGLT2 inhibitors that work by causing blood sugar to be secreted in the urine. They include AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana (canagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer. The FDA, in a warning on its website, said the medicines may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones. The FDA said its Adverse Event Reporting System database identified 20 cases of acidosis reported as diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 to June 6, 2014. It said all the affected patients required emergency room visits or hospitalization to treat the condition. Since June 2014, the agency said it had continued to receive additional adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors. The FDA warning also listed three combination type 2 diabetes treatments that include an SGLT2 drug as one of its two components, J&J's Invokamet, Xigduo XR from AstraZeneca and Lilly and Boehringer's Glyxambi. The medicines became popular in part because in addition to controlling blood sugar levels, they led to modest weight loss and slightly lower blood pressure. Obesity is a leading cause of type 2 diabetes and some older treatments cause weight gain. But the new FDA warning could help boost sales of alternative medicines, such as Merck & Co's Januvia. "I Continue reading >>
Merck’s Diabetes Dominance At Risk As Rival Drug Helps Out Heart
Diabetes isn’t looking as good as it used to for Merck & Co. To continue reading this article you must be a Bloomberg Professional Service Subscriber. Read this article on the Terminal Request a demo to learn more If you believe that you may have received this message in error please let us know. Continue reading >>
Oral Diabetes Medications
A list of oral diabetes medications with advantages, disadvantages, and side effects. Click on the name of a drug for more information. Biguanides Glucophage (generic name: metformin) Glucophage XR (generic name: metformin hydrochloride) extended release Fortamet (generic name: metformin hydrochloride) extended release Glumetza (generic name: metformin hydrochloride) extended release Riomet (generic name: metformin hydrochloride liquid) What are Biguanides? Metformin is the only member of the biguanides family in use today. Metformin (met-FOR-min) helps lower blood glucose by making sure your liver does not put extra glucose into the system when it is not needed. The ADA Standards of Medical Care in Diabetes recommend the inclusion of metformin (along with diet and exercise) in initial diabetes treatment. A good thing about metformin is that it does not cause blood glucose to get too low (hypoglycemia) when it is the only diabetes medicine you take. Who can take this medicine? Adults with type 2 diabetes can take metformin with their doctor’s approval and supervision. You should avoid metformin if you have liver or kidney problems, lung or heart disease, or conditions that cause low blood oxygen levels. Who should not take this medicine? People with certain types of heart problems, such as congestive heart failure, should use caution with this medicine. People with reduced kidney function or kidney disease should probably not take metformin. It should be used with caution if you regularly consume more than two to three drinks daily, so check with your doctor about that. Advantages Metformin, when used alone, is unlikely to cause low blood sugar. It is one of those medicines that always seems to help even after people have had diabetes for a while, and, for this reason Continue reading >>
Jardiance Vs Januvia
Januvia as a better treatment for Type 2 Diabetes? There are a lot of rumblings in the medical community at this very minute that lean in that direction. Yup! The medicalworld is on edge, awaiting results of an extended Jardiance study to be released later this month at the European Association for the Study of Diabetes annual meeting; thats when we will all see if the benefits of the SGLT2 med (Jardiance) That is also when the investments in either stock will swing in opposite directions. Get your dollars ready to make it rain shes bout to do a Stevie Mack is a blogger for many reasons, the main one being his love of entertainment. Visit his website here: _____________________________________________________________________________ While the markets gyrate rather wildly on concerns about emerging market growth or the lack thereof, more precisely we will take a moment tolook forward, into 2016-2017, and predict that (if this preliminary study result holds up, upon peer review) Jardiancemay eat into Mercks more than $5 billion franchise, here. The Boehringer Ingelheim/Lilly drug is an SGLT2 inhibitor, and Mercks only current bet in this space is in a venture shared with Pfizer . That venture effort is not likely to reach market before 2018, in my estimation. All of which is to say I think Merck would be quite vulnerable to product switching away from Januvia should Jardiance turn out to provide a reduced cardio-vascular risk to most diabetes patients. [As weve reported before, repeatedly, Mercks presently-available study data shows only that there isnoincreasedcardiovascular riskwith Januvia.] Speaking broadly, and oversimplifying, here longer term cardio-vascular events are generally the proximate cause of disability/death for people with advanced diabetes. So it stand Continue reading >>
Fda Clears Jardiance Combo For Type 2 Diabetes
FDA clears Jardiance combo for type 2 diabetes Combination treatment Synjardy is fifth drug to come from Boehringer/Lilly diabetes alliance Boehringer Ingelheim and Eli Lilly have been given US approval for Synjardy, which combines the SGLT2 inhibitor empagliflozin with metformin. The FDA approval for the combination therapy follows an EU green light in May and extends Boehringer and Lilly's Jardiance (empagliflozin) franchise, allowing the two companies to compete on equal footing with rival SGLT2 inhibitors in the fiercely competitive diabetes market. Johnson & Johnson's Invokamet (canagliflozin plus metformin) and AstraZeneca's Xigduo (dapagliflozin and metformin) already have marketing clearance in the US, getting the nod last year. Synjardy has been approved by the US regulator as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes who are inadequately controlled by a regimen containing empagliflozin or metformin, or in patients currently receiving empagliflozin and metformin. The rapid roll-out of combination therapies in diabetes is being driven by the recognition that tight glucose control is the key to avoiding the serious complications that occur once the disease has progressed, and simpler dosing regimens make that easier to achieve. It is estimated that currently around half of all type 2 diabetes patients fail to achieve their blood sugar control targets, so there remains a need for new treatment options. While their metformin combination lagged behind rivals, Boehringer and Lilly were the first to get approval in the US for a combination of an SGLT2 inhibitor with a DPP-4 inhibitor, a class which promises to become the dominant oral treatment for type 2 diabetes. In March they secured FDA approval for Glyxambi , whi Continue reading >>
Empagliflozin (jardiance): A Novel Sglt2 Inhibitor For The Treatment Of Type-2 Diabetes
Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes Uche Anadu Ndefo , PharmD, BCPS, Nicole O. Anidiobi , Efrah Basheer , and Angie T. Eaton , PharmD Dr. Ndefo is an Associate Professor in the Department of Pharmacy Practice at Texas Southern University in Houston, Texas. Nicole O. Anidiobi and Efrah Basheer are 2015 doctor of pharmacy candidates at Texas Southern Universitys College of Pharmacy and Health Sciences. Dr. Eaton is the Interim Chair of the Department of Pharmacy Practice at Texas Southern University. Drug Forecast is a regular column coordinated by Alan Caspi, PhD, PharmD, MBA, President of Caspi & Associates in New York, New York. Disclosure: The authors report no commercial or financial relationships in regard to this article. Diabetes mellitus is a lifelong condition requiring continuous medical care. Type-2 diabetes mellitus (T2DM), which accounts for approximately 90% to 95% of all diagnosed diabetes, is a progressive disease resulting from an insulin secretory defect characterized by insulin resistance and some degree of insulin deficiency. 1 Chronic long-term hyper glycemia associated with diabetes causes serious complications, including blindness, kidney failure, amputations, and death. The incidence of diabetes has increased dramatically in the United States over the last three decades, from 5.6 million cases to 21 million diagnosed cases in 2012. If this trend continues, one in three Americans will be diagnosed with diabetes by 2050. 2 , 3 The prevalence of T2DM has a tremendous impact on obesity, which is a growing problem for Americas health care system. Because of the rise in obesity, there is a heightened demand for researchers to develop drug therapies that are effective in treating hyperglycemia as well Continue reading >>
Compare Januvia Vs Jardiance - Comprehensive Analysis By Treato
I take januvia and jardiance now it isn't working. "I'm not doing good. My mental meds aren't working. Anxiety and panic all day long and I'm on 4 mg klonopin a day. I feel like I have the flu all the time. Fatigue is horrid. My blood sugar is over 600 today. I feel dehydrated all the time. My vision is blurry. My diabetes went crazy after they took me off of metformin because I simply wasn't tolerating it. I take januvia and jardiance now it isn't working. I saw Dr on Tuesday because I told him read more... I was going to quit my meds all 18 of them. She talked me into coming in for a emergency appointment the next morning. We talked over a hour. I had a full page of complaints. He is suspecting 3 autoimmune diseases so took blood for that. Now we wait for the results. Then this morning after starting the jardiance yesterday my blood sugar is over 600. So I called Kathy and she is getting to know over to Dr fist to see what he wants to do. She is suspecting that he will want me to go into the ER. I hate hospitals I'm very nervous and I don't know what to do. I just needed someone to talk to or a distraction I really miss the chat room hope its up and running again soon" Continue reading >>
Which Diabetes Drug Is Best?
TUESDAY, July 19, 2016 -- No single drug to treat type 2 diabetes stands out from the pack when it comes to reducing the risks of heart disease, stroke or premature death, a new research review finds. The analysis of hundreds of clinical trials found no evidence that any one diabetes drug, or drug combination, beats out the others. Researchers said the results bolster current recommendations to first try an older, cheaper drug -- metformin (Glumetza, Glucophage) -- for most patients with type 2 diabetes. "There are very few things experts agree on, but this is one of them," said Dr. Kevin Pantalone, a diabetes specialist at the Cleveland Clinic and a member of the Endocrine Society. "Metformin, in the absence of contraindications or intolerability, should be the first-line agent to treat patients with type 2 diabetes," he said. Metformin can cause upset stomach and diarrhea, so some patients are unable to stick with it day to day, explained Pantalone, who wasn't involved in the study. And people with kidney disease generally shouldn't take it, he said. More than 29 million Americans have diabetes -- mostly type 2, according to the U.S. Centers for Disease Control and Prevention. The disease, which is often linked to obesity, causes blood sugar levels to be chronically high. Over time, that can lead to complications, such as heart disease, stroke, kidney failure and nerve damage, the CDC says. There are numerous classes of medications that lower blood sugar levels. What's been unclear is whether any of those drugs work better than others in warding off diabetes complications and extending people's lives. The new analysis found no obvious winners. But the researchers also cautioned against drawing conclusions: The trials in the review were not specifically designed to see Continue reading >>
Sglt2 Inhibitors, Farxiga, Invokana, Jardiance. Dangerous New Drugs
The FDA recently gave its approval to several new drugs that are part of a new class of diabetes drugs, the SGLT2 inhibitors. All have very troubling side effects. More are awaiting approval. The first of these was Johnson & Johnson's drug canagliflozin, which is marketed in the U.S. as Invokana. It is also sold in a combination pill containing metformin as Invokamet. These sodium-glucose co-transporter-2 (SGLT-2) inhibitors lower blood sugar by blocking reabsorption of glucose by the kidney and increasing its excretion in urine. However, recent findings suggest that though these drugs increase excretion of glucose, they simultaneously increase the production of glucose by stimulating the secretion of glucagon. More about that can be read HERE. The manufacturers also claim that they cause weight loss--always a potent selling point for a diabetes drug. Most recently, a questionable research study has been the basis of the claim that one of these drugs actually prevents heart attacks. The facts are quite different, but drug company flacks are saturation bombing family physicians with materials that make it sound like they should put every patient with Type 2 on this wonderful, new drug, which is priced at $8.77 a pill or $263.10 for a monthly supply. They shouldn't. When the first of these drugs, Invokana (canagliflozin), came up for approval, the committee of "experts" who reviewed it were ambivalent about it because the company's own, [most likely, statistically manipulated], clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event [mainly strokes and some heart attacks] compared with just one patient taking a placebo. After that, the imbalanc Continue reading >>
Lilly And Bi's Jardiance Could Shake Up Sglt-2 Market
Lilly and BI's Jardiance could shake up SGLT-2 market Lilly and BI's Jardiance could shake up SGLT-2 market Lilly and BI's Jardiance could shake up SGLT-2 market Eli Lilly and Boehringer Ingelheim's SGLT-2 inhibitor and type 2 diabetes treatment Jardiance (empagliflozin) received FDA approval this past Friday. Although it enters a crowded category, the drug's competitive profile may win the day. SGLT-2 inhibitors are an important new class of drugs for diabetics. These agents are used as add-ons for patients taking oral hypoglycemic drugs or insulin to help control their high blood sugar. Johnson and Johnson's Invokana was the first SGLT-2 to be approved in March 2013. Although J&J will not disclose exact sales for Invokana, the drugmaker reported in its second quarter earnings that Invokana sales contributed over 2.5 points to [its] U.S. pharmaceutical growth rate and for the quarter achieved 2.3% total prescriptions within the defined market of type 2 diabetes, and total prescriptions with endocrinologists grew to 7% for the quarter, up approximately 1% sequentially. A year in perspective, accompanied by those figures, has led J&J to declare Invokana as the most successful launch in type 2 diabetes since Januvia, although the folks at AstraZeneca may contest that distinction. AstraZeneca's own SGLT-2 inhibitor Farxigawhich AZ acquired in its diabetes deal with BMS last yearwas launched this past May. Out of the gate, the drugmaker has called the US debut excellent, as well as one of the most successful launches in the overall non-insulin anti-diabetic markets since Januvia. AZ, too, has not disclosed sales figures. And it's not hard to see why that's an attractive comparison for either drugmaker. US sales for Merck's Januvia were $2.8 billion last year, second only t Continue reading >>
Combination Of A Dpp-4 And An Sglt-2 For Type 2s
Home / Conditions / Type 2 Diabetes / Combination of a DPP-4 and an SGLT-2 for Type 2s Combination of a DPP-4 and an SGLT-2 for Type 2s New treatment strategies have focused on both dipeptidyl peptidase (DPP)-4 inhibitors, and SGLT-2s. DPP-4s improve hyperglycemia by stimulating insulin secretion in a glucose-dependent fashion and suppressing glucagon secretion, and sodium-glucose co-transporter-2 (SGLT2) inhibitors, which reduce renal glucose reabsorption and induce urinary glucose excretion, thereby lowering plasma glucose. The potential complementary mechanism of action and good tolerance profile of these two classes of agents make them attractive treatment options for combination therapy with any of the existing glucose-lowering agents, including insulin. Together, the DPP-4 and SGLT2 inhibitors fulfill a need for treatments with mechanisms of action that can be used in combination with a low risk of adverse events, such as hypoglycemia or weight gain. Dipeptidyl peptidase (DPP)-4 inhibitors enhance postprandial insulin secretion and suppress glucagon secretion by preventing the degradation of endogenously released incretins [glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic polypeptide (GIP)], two intestinal peptides whose concentration increases after food intake, thus playing a vital role in glucose homeostasis. DPP-4 inhibitors stimulate insulin secretion in a glucose-dependent fashion and inhibit glucagon secretion, thus minimizing hypoglycemia and improving hyperglycemia. In addition, DPP-4 inhibitors are weight-neutral and have been shown to improve -cell function in in vitro and animal studies. These characteristics may provide benefits to those people with T2DM who have impaired -cell function, excessive hepatic glucose production, postpra Continue reading >>
Januvia And Jardiance Drug Interactions - Drugs.com
Do not stop taking any medications without consulting your healthcare provider. Disclaimer: Every effort has been made to ensure that the information provided by Multum is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. Multum's information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill, knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2018 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist. Some mixtures of medications can lead to serious and even fatal consequences. Continue reading >>
